SENATE MAJORITY LEADER URGES DRUG INDUSTRY TO STOP DIRECT-TO-CONSUMER ADVERTISING (DTCA) FOR THE FIRST TWO YEARS A NEW DRUG IS ON THE MARKET

Lawmakers as well as the American Medical Association (AMA) are finding it more and more difficult to ignore the escalating problems associated with DTCA.

The American Medical Association (AMA) considered the issue and, although several proposals that called for the AMA to support a ban on DTCA were rejected by the AMA’s policy making House of Delegates, the issue was sent to the Association’s Council on Science with a directive to deliver a detailed report on the subject at the next AMA meeting in December.

Earlier this year, Senators Charles Grassley (R., Iowa) and Christopher Dodd (D., Conn.) proposed a new FDA board, which would have as one of its functions, evaluating DTCA before it is released to the market.

Now, Senate Majority Leader Bill Frist has openly requested pharmaceutical companies to stop DTCA for the first two years a new drug on the market. The industry is aware it must make serious changes in its advertising approach; however, so drastic a unilateral move on its part is unlikely.

There is little doubt that prescription drug marketing tactics are under close scrutiny at this time. No aspect of marketing strategy is more controversial than DTCA.

While some experts maintain that DTCA actually strengthens our health care system, others are equally certain that DTCA has caused many of the problems that plague the drug industry (over-medicating, over-pricing, and exaggerated and often misleading advertising claims). There are even those who strongly urge that DTCA “must be banned as part of FDA reform.” (http://www.newstarget.com/z003204.html)

A growing number of doctors and other healthcare professionals believe that any perceived benefits from DTCA are far outweighed by the problems it has caused and the burden it has placed on the FDA to regulate the content and accuracy of thousands of TV, radio, print, and online advertisements. The FDA Division of Drug Marketing, Advertising and Communications has about three dozen employees to review 30,000 to 40,000 DTC ads each year.

Today, drug advertising has become an industry unto itself and inadequately tested and hastily marketed drugs permeate the market and expose the public to great risk.

In 1989 DTCA spending totaled $12 million. By 1992 that figure had jumped to $156 million. When TV and radio ads were added to the mix, spending began to take off, reaching $844 million in 1997 and $1.58 billion in 1999. The figure then soared to $2.38 billion in 2001 and is now in the vicinity of $3.8 to 4 billion.

All of this spending is not without reward, however. A recent study by researchers at Harvard University and the Massachusetts Institute of Technology analyzed the effect of DTCA advertising on consumer spending for prescription drugs. The study found that a 10% increase in advertising of drugs within a therapeutic drug class resulted in a 1% increase in sales of he drugs in that class.

When these findings were applied to the 25 largest drug classes in 2000, it was found that every $1.00 spent on DTCA yielded $4.20 in drug sales. DTCA was thus responsible for 12% of the increase in prescription drug sales or an additional $2.6 billion in 2000 alone.

Another study conducted (between 1999 and 2000) by the National Institute for Health Care Management (NIHCM) found that DTCA resulted in significant increases in retail spending.

The study found that the 50 most heavily advertised drugs were responsible for 47.8% of the increase in retail spending on prescription drugs between 1999 and 2000 (some $9.95 billion) while increases in sales of some 9,850 other drugs on the retail market accounted for 52.2% of the one-year rise in retail pharmaceutical spending (about $10.86 billion).

In a perfect world, the benefits of DTCA touted by some experts would be quite understandable and even warranted. Many experts see the serious problems plaguing the system as making any such praise undeserved. Some of those problems include:

• Repeated findings by the FDA that many ads are deceptive, inaccurate, misleading, and otherwise in violation of federal law.

• The FDA is forced to expend an ever-increasing portion of its budget and manpower on policing advertising instead of more carefully investigating new drug applications and adverse reaction reports.

• DTCA takes valuable assets away from research and development.• DTCA drives up the retail price of drugs.• DTCA results in over medicating the public.• DTCA results in expensive drugs being taken by patients who would be better off taking safer and cheaper alternatives already on the market.• DTCA leads people taking drugs they do not need in the first place.• DTCA eliminates the “learned intermediary” (physician) from the decision making process in many cases and, in others, doctors are placed in the awkward position of having to prescribe a drug or lose a patient. • DTCA uses celebrities, athletes, and even retired news anchors (who have no medical or pharmaceutical training) to vouch for the safety and effectiveness of prescription drugs.

• DTCA uses music which is (or was) popular with the target audience in order to subconsciously influence choice. • Warnings are confined to extremely small type at the bottom of the page or TV screen and rapidly spoken segments of commercials.

• DTCA capitalizes on the widely held but erroneous belief among consumers that “newer is better.”• DTCA ultimately places marketing above science.

The FDA often issues stern warnings to drug companies about misleading or deceptive statements or unproven claims of superiority. These warnings, however, are usually not made public. In fact, they are even sometimes ignored by the offending company or not acted upon for months or years.

Recently, pharmaceutical giants such as Merck, Pfizer, Bayer, and GlaxoSmithKline have received warning letters from the FDA regarding the use of false or misleading advertisements and promotional materials.

Merck, the manufacturer of Vioxx, the Cox-2 inhibitor that was pulled from the market in September of 2004, was warned as far back as September 2001 that their promotional activities and materials were “false” and “lacking in fair balance.”

In addition, Merck’s promotional campaign minimized the now-known serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study.

Pfizer also received a warning letter (January 2005) identifying five promotional pieces for the Cox-2 inhibitors Bextra and Celebrex which, according to the FDA’s letter: “omit material facts, including the indication and risk information; fail to make adequate provision for the dissemination of the FDA-approved product labeling; and make misleading safety, unsubstantiated superiority, and unsubstantiated effectiveness claims.”

The FDA claimed that the ads in question, such as the one featuring a woman playing the long version of a song on the guitar and a 27-minute long infomercial featuring “regular people” talking about their arthritis pain, are misleading because of their overstatement of effectiveness as well as the omission of risk information.

GlaxoSmithKline was likewise warned about misleading advertisements for its hypertension drug called Coreg.

In April, the FDA ordered Bayer and GlaxoSmithKline to withdraw certain commercials for the erectile dysfunction drug, Levitra. The FDA found the 15-second ad did not state possible side effects, did not prove its claim of superiority over competing drugs, and could not substantiate the claim that it gives female partners greater sexual satisfaction.

As recently as November 2004, Pfizer was ordered to pull an ad for Viagra off the air for similar reasons. Thus, it was not as if the drug industry had not been warned of this improper advertising approach with respect to the very same class of drugs.

On May 6, in a strongly worded letter, the FDA advised pharmaceutical giant Pfizer Inc., that one of its direct-to-consumer (DTC) print advertisements for the powerful anti-depressant psychotropic drug Zoloft “is false or misleading because it omits important information relating to the risk of suicidality in patients taking Zoloft, in violation of the Federal Food, Drug, and Cosmetic Act…and implementing regulations…This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug.” The letter as well as a warning to health care professionals was also posted on the FDA’s website. The FDA has also issued an alert concerning Zoloft and the risk of pediatric suicide. Thus, rather than demonstrate a full commitment to truthful advertising, pharmaceutical companies are often caught attempting to mislead the public.

This untrustworthiness forces the FDA to divert valuable resources (money and manpower) from investigating new drug applications and adverse events related to existing drugs.

DTCA has been blamed for COX-2 inhibitors like Vioxx, Celebrex, and Bextra being greatly over-prescribed for years especially to patients who never needed them in the first place.

Over-medicating is a very serious problem and it is occurring more and more frequently with respect to the most advertised drugs such as those for pain, high cholesterol, gastrointestinal disorders, depression, and disorders that cause embarrassment (incontinence, herpes, yeast and fungal infections, and erectile dysfunction).

In addition, the fact that COX-2 inhibitors cost between 10 and 15 times more than cheaper, safer, and equally effective painkillers such as naproxen, ibuprofen, and aspirin was never conveyed in any of the DTCA. This is a common occurrence in DTCA of designer drugs and one that greatly increases the cost of healthcare.

Of course as healthcare expenditures rise, so does the cost of health insurance and government programs that subsidize health benefits to senior citizens and those of limited means.

While many DTC advertisements feature unknown actors or voiceovers, a significant number of ads rely upon celebrities, athletes, and famous musical recordings to entice the public. Prominent broadcast journalists such as Walter Cronkite and Aaron Brown were used to blur the line between journalism and advertising. Critics argue that this kind of DTCA misleads viewers by “packaging promotional material to look like news.”

Although one would like to believe that a doctor will only be guided by his medical training when deciding whether to prescribe a drug, that is not always the case. Doctors are often faced with patients who literally demand to be given a certain drug based on nothing more than a slick TV ad. Surveys have shown, however, that doctors too can be prone to believing that “newer is better.”

A study published in the April 27 issue of the Journal of the American Medical Association used 18 actors pretending to be patients to make 300 visits to 152 doctors’ offices with fake psychological symptoms. The actors also mentioned seeing the ad for the antidepressant Paxil.

When complaints of stress and fatigue were mentioned, the actors were five times more likely to be given a prescription when they mentioned the Paxil ad. Most of the actors who did not complain of depression were not given prescriptions, but when they specifically asked for Paxil, 55% were given prescriptions and 50% received a diagnosis of depression.

The important thing is to determine, with the help of a physician and truthful information from the drug companies, what the correct medical decision is for the patient. Consumers should not be making these decisions. Unfortunately, this is exactly what DTCA seeks to do as one of its goals.

Dr. Frist firmly believes, as do most experts on the subject, that skyrocketing advertising costs have encouraged “inappropriate prescribing” and higher drug prices. As a result, he has asked the Government Accountability Office to investigate the FDA’s supervision of DTCA, the level of spending for DTCA, and the effects of DTCA on patient awareness, education, and other matters.